Advanced Sterilization Products: Medical Device Recall in 2013 - (Recall #: Z-0044-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Product Classification:

Class II

Date Initiated: September 18, 2013

Date Posted: October 30, 2013

Recall Number: Z-0044-2014

Event ID: 66317

Reason for Recall:

Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.

Status: Terminated

Product Quantity: 2,995 units

Code Information:

Lot# 13F050, 13F051, 13F049

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated